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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

DHHS Plans to Assess Need for Revisions to Human Research Protections at Upcoming Meeting

Posted 21 September 2012 | By

The US Department of Health and Human Services (DHHS) is planning to meet in October to discuss whether current protections afforded to human research subjects are adequate, or whether new regulations and guidelines are needed.

The meeting, announced in the Federal Register on 20 September, will involve DHHS' Secretary's Advisory Committee on Human Research Protections (SACHRP). The group, which acts as an advisory committee, is charged with providing recommendations to DHHS on issues of human research, and specifically on how to protect human subjects participating in research.

The meeting will specifically address reports generated by the group's various subcommittees, which have recommended revisions to the expected responsibilities of principal investigators, informed consent waiver criteria, the expedited review process, local context of trials, the use of the Internet in subject research and informed consent procedures in cluster randomized trials.

The meeting will take place on 9-10 October 2012 at DHHS' Washington, DC campus.